Personalis, Inc
Location
Fremont, CA | United States
Job description
Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' Clinical Laboratorywas built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited.
Summary:
The Sr. Document Control Specialist is an integral member of the Quality team. The primary responsibility is to maintain the daily activities within the Document Control function. The Sr. Document Control Specialist has knowledge and experience working in regulated environments (i.e. ISO 13485, 21 CFR Part 820, 21 CFR Part 11) and sufficient knowledge and experience using electronic Quality system (eQMS) and be able to operate with minimal supervision. This position reports to Associate Director, Document Control.
Responsibilities:
• Participate in the development, implementation, and maintenance of the Quality Management System
• Work on Document Control activities either independently or with minimal supervision.
• Ensure documentation and data related to the requirements of the Quality System are controlled in a manner, which ensures integrity and accessibility.
• Ensure document control activities such as document management, version control, distribution and reporting management are executed in a timely fashion and in accordance with regulatory requirements.
• Update and maintain document control procedures and record keeping database.
• Perform training on Document Control process
• Reviews all documents for change to ensure the use of correct templates and key quality requirements and resolves issues with the initiator of the change.
• Ensure that the current revision of a controlled document is clearly defined in order to preclude the use of non-applicable documents.
• Maintenance of all applicable records such as validation reports, test reports, batch records and training records (internal and external training) as defined by applicable regulations and standards.
• Support the maintenance of periodic document review
• Mentor and train team members in Document Control processes
• Work on multiple projects simultaneously.
• Duties also may include word processing, filling quality records, and other project related activities as needed.
• Create and present Quality metrics and trends as needed
• Support audits for licensure and accreditation documents submission
• Assist in the management of onsite and offsite records.
• Support in the implementation of new eQMS
• Support Training manager on training requirements as needed
• Participate in group meetings and present results.
• Supports and ensures compliance with all department and company policies and procedures.
• Communicates effectively across teams to explain methodology, process, and results from analysis.
Education and Experience:
• 5+ years’ experience using electronic document control system is required (which demonstrates compliance with applicable regulatory requirements, or similar document creation, filing/archiving experience)
• Knowledge of document control management systems such as Omnify or Compliance Quest is a big plus
• Bachelor’s in life or computer science preferred
• Strong desire to work in a demanding, high-energy, hands-on startup environment
• Ability to primarily work independently
• Candidate must be detail oriented, to review documents with specific requirements in mind and ensure the posting process is completed.
• Ability to prioritize and organize workload to meet business needs and turnaround time requirements.
• Strong abilities in Microsoft Office applications.
• Excellent technical writing and verbal communication skills.
• Expert in Microsoft Word, Excel, and PowerPoint
• Familiar with Google Suite
• Customer orientation – works in a supporting role and communicates with cross functional teams and partners at all levels in the organization.
• Follow through - completes the tasks and any needed follow up activities, including escalation of system errors and past due documents.
• Experience working on a regulated Medical Device or Pharma environment
The hiring range for this position is $72,000 to $92,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.
Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contacts you.
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package and benefits including medical, dental, vision, 401(k) match, ESPP, tuition reimbursement, sick/vacation time, commuter benefits/ EV charging stations, onsite gym, and wellness benefits. (For US only, benefits in other countries may vary.)
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